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107

IEC 60601-1-2: Table 201

Guidance and manufacturer's declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified

below. The customer or the user of the device should ensure that it is used in such

an environment.

Emissions Test

Compliance

Electromagnetic environment – guidance

RF Emissions CISPR 11

Group 1

The device uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to

cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

The device is suitable for use in all establishments, including

domestic establishments and those directly connected to the

public low-voltage power supply.

Harmonic Emissions Class A

IEC 61000-3-2

Class A

Voltage Fluctuations/Flicker

Emissions IEC 61000-3-3

Complies

Содержание MICRO-PUMP

Страница 1: ...INSULIN PUMP SYSTEM MANUAL ...

Страница 2: ... of your diabetes and will help you live a healthy and active life This user guide is designed to help you understand insulin pump therapy and the operation of your Wellion MICRO PUMP We strongly recommend that you work closely with your healthcare professional to ensure you understand the pump functions and can begin therapy safely and effectively ...

Страница 3: ...ucose Test Module Precautions 11 Important Safety Information 12 Component Description 13 Pump System Components 13 Accessories 13 Getting Started 15 PDA Setup 15 Charging the Batteries 18 Settings Wizard 20 Home Screen 26 Lock Screen 29 Basal Rate Adjustment 31 Understanding Basal Rate 31 Base Basal Rate 31 Editing Basal Programs List Display 31 Editing Basal Programs Graph Display 35 Activating ...

Страница 4: ...48 Removing the Infusion Set 50 Filling the Reservoir 50 Assembling Reservoir to Pump 52 Disassembling the Reservoir 53 Replacing the Pump 54 Replacing the Reservoir 58 Setup 58 The Built in Blood Glucose Meter 62 Operating Principle 62 Application 62 Blood Sampling 62 Fingertip Testing 63 Lancet Removal 65 Ejecting Test Strips 66 Testing Blood Glucose 66 Comparing Meter and Lab Results 68 ...

Страница 5: ...g the Bolus Calculator 76 Settings 78 History 80 Viewing Your History 80 Historical Averages 81 General Settings 83 Time and Date 83 About the System 83 Language 84 Memory Card 84 Display 84 User Settings 84 Bluetooth 85 Additional Features 87 Audio Player 87 Auto Off 87 Food Database 87 Suspend Resume 88 How to Suspend Resume 88 Alarms and Troubleshooting 89 ...

Страница 6: ...autions 99 Wireless Connection 99 Disposal 100 Transportation 100 Storage 100 Other Considerations 101 Specifications 102 General Specifications 102 Delivery 103 Blood Glucose Meter 103 Bolus Calculator 104 Bolus Delivery 104 Infusion Precision 104 Occlusion Detection Maximum Infusion Pressure 105 Occlusion Alarm Time 105 Overdose Underdose 105 Electromagnetic Compatibility 105 Appendix 111 Symbol...

Страница 7: ... 30 to 55 2 Triglyceride concentration does not exceed 3 000 mg dL 33 9 mmol l or cholesterol concentration does not exceed 500 mg dL 12 8 mmol l 3 Non critically ill patients such as those with severe dehydration or ketoacidosis etc Contraindications This insulin pump system is NOT suitable for patients who Are unwilling to receive insulin treatment Are unable to control their blood glucose or un...

Страница 8: ... up 48 scheduled basal rate changes within one day However if you are new to using an insulin pump you may decide to only use one or two basal rates during the day 2 Active Insulin Time The length of time that insulin remains active and available in your body after a correction bolus Quick acting U100 Insulin should be used in the pump 3 Target Blood Glucose Level Insulin pump therapy requires a t...

Страница 9: ...re professional to help with first time setup and training of the insulin pump system Please seek help from your healthcare professional if you encounter problems Your localWellion provider can provide technical support for the device but cannot provide treatment advice for your medical condition Prepare for Emergencies Patients with diabetes should always carry an emergency kit to quickly respond...

Страница 10: ...the therapy is stable You should keep in frequent contact with your healthcare professional Basic pumpadjustmentsshouldbemadeonlyunderclosesupervisionwithaqualified person You should have sufficient knowledge of diabetes and how to regulate your blood glucose level using insulin delivery and diet You should understand the effects of hyper and hypoglycemia and how to prevent these conditions If the...

Страница 11: ...30 Blood containing high levels of vitamin C or other reducing agents can lead to inaccurate results The blood glucose meter test range is 1 1 33 3mmol L 20 600 mg dL Triglycerides above 3 000 mg dL 33 9 mmol l and cholesterol above 500 mg dL 12 8 mmol l will lead to inaccurate test results Patients with serious illness such as severe dehydration or ketoacidosis are not suitable for measuring bloo...

Страница 12: ... the pump from the base check your blood glucose level and take precautions as necessary Symptoms of high blood glucose include fatigue excessive thirst and nausea You should always contact your healthcare professional if you experience excessively high or low blood glucose levels or if you have any questions about your care Static Electricity The insulin pump system is resistant to normal levels ...

Страница 13: ...13 Component Description Pump System Components Portable Diabetes Assistant PDA Pump Bolus Button Motor System Battery contacts Accessories 1 Cannula Inserter 2 Pump Battery 3 Pump Battery Charger ...

Страница 14: ...C 110V 250V 50 60Hz Connection to outlets that are outside this range can cause damage Note Only use electrical components and accesso ries branded Wellion Other accessories may lead safety problems including inaccurate insulin delivery The manufacturer and MED TRUST cannot be liable for problems arising from the use of third party accessories Pump MTM 1 Portable Diabetes Assistant PDA MTM 2 Cannu...

Страница 15: ...manufacturer Use of third party accessories may cause unexpected behavior and will void your warranty Getting Started PDA Setup 1 Remove the battery cover Holding the PDA firmly with one hand pry up the battery cover by inserting your fingernail until the slot shown in Figure 1 2 Insert a microSD memory card Insert memory into the slot as shown in Figure 2 4 Replace the Battery Cover Replace the b...

Страница 16: ...N Press and hold this key and the PDA will vibrate begin the startup process and enter the home screen after about 30 seconds Screen Off If the PDA display is on pressing the Power Button will turn off the LCD display and the PDA will enter standby mode 1 10 11 5 9 7 8 6 2 3 4 12 13 Figure 5 Screen On When in standby pressing the power button will turn on the display and present the lock screen ...

Страница 17: ...he help button for more information 3 Home Screen Button Press this to return to the home screen 4 Back Button Press this to return to the previous screen or close a dialog box 5 Up Button This can be used to navigate the interface without using the touchscreen Choose up to change selection 6 Down Button This can be used to navigate the interface without using the touchscreen Choose down to change...

Страница 18: ... 8 Display 3 2 inch color display with touchscreen 9 Charger Data Port Connect the PDA charger to this port to replenish the battery This port can also be used to transfer data to a personal computer using a data cable 10 Blood Glucose Test Strip Port Inserting the correct Wellion MICRO blood glucose test strip into this port will activate the blood glucose test menu For more information on how to...

Страница 19: ...ry Charger 1 The pump battery is inserted into the charger as shown in Figure 7 You should hear a click sound indicating that the battery is correctly inserted 2 Insert the small end of the cable into the pump battery charger as shown in Figure 8 The large end of the cable should be inserted into the PDA charger 3 Plug the PDA charger into a wall outlet and the blue LED will turn on indicating tha...

Страница 20: ...charger when plugged into a wall outlet as it is a potential shock hazard 5 Remove the pump battery as shown in Figure 9 lift the battery up from the charger groove Note When you are in the SettingsWizard the Home button and Back button will not work until you finish the Wizard 1 Time and Date Settings After entering the Settings Wizard you will be presented with the Time and Date setup screen sho...

Страница 21: ...the Time setting to open a dialog box Figure 12 that can be used to input the time Use the and buttons to select the time choose OK to save and exit or Cancel to exit without saving Figure 11 Figure 12 Note If the 12 hour format is chosen am and pm will be shown Figure 13 Figure 13 c If 24 Hour Format is checked the time and history data will be displayed in 24 hour format Uncheck the box to use 1...

Страница 22: ... 15 that can be used to input the maximum basal rate Use the and buttons to select the appropriate maximum rate Choose OK to save and exit or Cancel to exit without saving Figure 15 Figure 16 b Choose the Base Basal Rate setting to open a dialog box Figure 16 that can be used to input your base basal rate Use the and buttons to select the appropriate value Choose OK to save and exit or Cancel to e...

Страница 23: ...delivered per hour Figure 17 Temporary basal rates will be displayed relative to your current basal rate After you have finished choosing the Basic Basal settings choose Next to enter the third Settings Wizard screen or Previous to enter the previous setting screen 3 Basic Bolus Settings The third screen in the Settings Wizard shows the Basic Bolus settings Figure 18 Figure 18 Note For a more deta...

Страница 24: ... of bolus delivery that can be administered by accident or misoperation c Choose the Extended Bolus setting to open a dialog box Figure 21 that will give you options Off Extended Bolus function is disabled Extended Bolus controls will be greyed out U Amount now will be shown in U units of Insulin Amount now will be shown as a percentage of the entire bolus After you have finished choosing the Basi...

Страница 25: ... are relatively advanced and your local Wellion MICRO PUMP representant recommends proper training and practice before using these features a The Quick Bolus function allows the user to administer a bolus using only one button This feature is turned off by default For more detailed information about this feature see Chapter Boluses Settings b The Bolus Calculator can help the user decide on the si...

Страница 26: ...izard Note After you complete the SettingsWizard you can use all of the basic functions of the pump system However please read the additional sections of this user guide as they describe the features in greater detail Figure 26 Status Bar Information Display Area Function Buttons 6 Alert Options The fifth screen in the Settings Wizard shows the Alert Options Figure 25 If you choose the Low Reservo...

Страница 27: ...t appears this icon will appear on the status bar Insulin Remaining Shows how much insulin remains by varying degree if PDA wireless link is poor it displays Pump Battery Level Shows the pump s battery level status in varying degrees if PDA wireless link is poor it displays Wireless Link Status Shows the wireless link strength between pump and PDA It displays when the connection is totally lost Bl...

Страница 28: ...cial functions bolus delivery temporary basal rates and suspend mode the Information Display Area will show the status of those functions until the actions are completed Function Buttons 1 Bolus Pressing this button takes you to the Bolus Screen where you can administer a normal or extended bolus 2 Basal Pressing this button takes you to the Basal Screen where you can adjust your basal programs or...

Страница 29: ...riod of non use the display can be turned on again by pressing the power button The PDA will enter the lock screen as shown in Figure 28 The Lock Screen is divided into three main sections Time and Date Information Display Area and the Unlock Area 5 Settings Press this to go to the Settings Menu 6 Suspend Resume Pressing this button allows you to quickly suspend or resume insulin delivery Figure 2...

Страница 30: ...vel the last bolus administered and the current basal rate or the status of a special function Unlock Area Unlock the device by swiping from left to right in this area Note The content of the Information Display Area in the Home Screen is identical Note You can also unlock the PDA by simultaneously holding the Down and bolus buttons ...

Страница 31: ...p the base basal rate in the Settings Wizard The base basal rate is the default basal rate for your basal programs In the next sections you will learn to edit a basal program by modifying the base basal rate in different time periods Editing Basal Programs List Display In the Home Screen press the basal function button to enter the basal screen shown in Figure 29 You will see three Basal Program T...

Страница 32: ...e Basal Time Period List Swipe up or down in this area to scroll and see hidden list entries 2 Reviewing Basal Programs The PDA provides the ability to run one of three basal programs You can review different basal programs by choosing one of the Basal Program Tabs 3 Quick Basal Program Setup The pump provides a Quick Basal Program Setup option By entering your total daily basal insulin and choosi...

Страница 33: ...time period press the Change Settings button to enter the basal edit screen as shown in Figure 31 Press the button to add a new basal time period Figure 32 After editing is complete Figure 33 the base rate time will automatically be divided into multiple time periods Figure 31 Figure 32 Figure 33 Afterenteringthesesettings thesystemwillautomaticallyassignBasalTimePeriods to the Basal Program Now y...

Страница 34: ...Change Name dialog box Figure 34 Change to the desired name Figure 34 6 Saving Settings After you have completed editing the basal program press Save Settings to save and exit the Basal Edit screen Note If you have edited a basal program that is currently running on the pump a dialog box will open asking if you would like to send the updated program to the pump Choose OK to update and save or Canc...

Страница 35: ...vertical axis of the chart represents the basal rate while the horizontal axis represents the time which shows 24 hours of the day 2 Add a Basal Time Period a In the graph display press and hold on any area of the graph to enter the edit mode as in Figure 36 The highlighted area is the period to be edited Figure 36 Note You cannot switch between Basal Programs in Graph Display mode You must return...

Страница 36: ...en press the Basal Function Button to enter the Basal Screen shown in Figure 29 Select the correct basal program by choosing the correct tab Press the Activate Program Name button and confirm using the dialog box Temporary Basal Rate Normally your basal rate does not require frequent changes but in certain circumstances you may want to temporarily administer a different basal rate to avoid low or ...

Страница 37: ...ry Basal Rate button to bring up a temporary basal rate settings dialog box Figure 37 Enter your temporary basal rate and the amount of time Press the Begin button and the PDA will send the command to the pump to administer a temporary basal rate When the command is completed the PDA will automatically return to the Home Screen where the Information Display Area will show the current status of you...

Страница 38: ...orary Basal Rate function The corresponding Temporary Basal Rate button will be greyed out b U hr Temporary Basal Rate will be displayed in U hr c Temporary Basal Rate will be displayed as a of the current basal rate 2 Base Basal Rate Used to enter the Base Basal Rate Chapter Base Basal Rate Figure 39 Note This feature is used to limit the maximum amount of basal delivery that can be administered ...

Страница 39: ...food intake Manual Boluses Manual boluses are used to offset high blood glucose levels From the Home Screen choose the Bolus button to enter the Bolus Screen Figure 41 Choose the Bolus button in the upper left corner to open the dialog box Figure 42 Choose your bolus size and press OK If the Bolus amount is not 0 the Start button will be green and you can choose the Start button to begin to admini...

Страница 40: ...3 Bolus Presets Unaprijed zadane postavke bolusa Bolus ekran sadrži tri programirana unaprijed zadana bolusa slika 44 While the pump is delivering the PDA will revert to the Home Screen and display the bolus status Figure 43 ...

Страница 41: ...will appear that links the preset that has been chosen to the bolus amount Figure 46 You can administer the bolus now by pressing the Start button as in Chapter Manual Boluses 3 Edit Preset Press the icon to open the Preset settings dialog box Change the settings and press OK to save Figure 45 Figure 46 Note All three presets can be administered in any order but only one can be administered at a t...

Страница 42: ...uses Settings Amount Now the bolus amount to be administered immediately Extend amount Total Bolus Amount Now ExtendTime The time period over which the extended amount will be administered An Extended BolusWith Amount Now is a bolus that is administered in two stages an amount immediately and the remainder over an extended period of time Note This feature requires a detailed understanding of one s...

Страница 43: ...ded Bolus Without Amount Now can be administered over a time period of 30 minutes and 8 hours Figure 49 Before using this feature please read Chapter Extended Bolus with Amount Now To administer an Extended Bolus Without Amount Now set the Amount Now to 0 zero No immediate bolus will be administered and the total bolus amount will be administered over the time period specified Quick Bolus The Well...

Страница 44: ...es Settings Also every time you press the Enter Select button you will hear a beep from the PDA to confirm that you have pressed the button Each time you press the button the tone will ascend in pitch up to 5 and then repeating to help you remember the number of times you have pressed the button 3 After you have set the correct bolus amount by pressing the Enter Select button the appropriate amoun...

Страница 45: ...er the number of times you have pressed the button Note The maximum number of increments for a quick bolus is 20 Note If there is no activity for 10 seconds the pump exits the Quick Bolus mode Note If you would like to cancel simply wait 10 seconds for the system to exit the Quick Bolus mode 3 After you have set the correct bolus amount wait for 3 seconds and the pump will repeat the audible tones...

Страница 46: ...min Use this menu to decrease the bolus rate to 1 5U min 2 Bolus Increment Setting This is the amount that the requested bolus changes when pressing the or button 3 Maximum Bolus Setting This is the maximum bolus that the user can choose in the bolus menu Press the Cancel button and a confirmation window will appear in PDA Press OK to confirm You can also cancel a bolus by pressing and holding the...

Страница 47: ...s Check the checkbox next to Quick Bolus to enable the Quick Bolus function Additional Quick Bolus settings will be activated a Quick Bolus Increment Sets the amount that the bolus increases with every Quick Bolus button press ...

Страница 48: ...least 2 3cm away from your navel Do not use the abdomen if you are late in pregnancy Figure 52 Figure 53 Front Back 2 Open the cannula pack as indicated on the packaging Push the cannula assembly into the cannula inserter as shown in Figure 53 until the cannula assembly is in the cocked position and you hear two click sounds You should see that the cannula assembly is connected firmly to the cannu...

Страница 49: ...he cannula as shown in Figure 56 If the inserted needle or needle base remains on the cannula carefully remove it from the infusion site Place the protective sleeve back onto the cannula assembly 6 If the needle remains in the inserter place the protective sleeve back onto the needle hub Firmly push the top of the inserter to eject the needle hub Figure 57 and dispose of properly Figure 54 Figure ...

Страница 50: ...he fill adapter as in Figure 59 3 With the insulin vial on top slowly pull the pullrod and draw insulin into the reservoir as in Figure 60 4 Tap the side of the reservoir to encourage any air bubbles to rise to the top of the reservoir Figure 61 5 Push the pullrod slowly to eject the bubbles back into the vial and then slowly pull to draw more insulin into the reservoir Repeat until the reservoir ...

Страница 51: ... 7 Pull the two release tabs shown in Figure 64 away from the reservoir to release the fill adapter 8 Remove the pullrod by unscrewing it counterclockwise Figure 65 Note The fill adapter contains a needle please dispose of properly Figure 63 Figure 64 Figure 65 ...

Страница 52: ...gure66illustratesthesequencetoattachthereservoir and battery to the pump Always install a fully charged battery with a newly filled reservoir Be sure that the battery is inserted in the orientation shown in Figure 67 Figure 66 Figure 67 ...

Страница 53: ... until the reservoir separates from the pump Be sure to recharge the battery immediately to make sure that a fresh battery is always installed with a new reservoir Dispose of the used reservoir in a medical sharps container Note Pay close attention to the orientation of the pump during disassembly Incorrect disassembly may cause damage Figure 68 ...

Страница 54: ...s how to connect a new pump to the PDA or replace an old one 1 From the Home Screen choose the Actions button and then the New Pump button to enter the New Pump Wizard Figure 70 a If this is your first time using the wizard to connect your pump the wizard will start with Figure 69 Apply a new infusion set Chapter Infusion Set Setup Assemble a filled reservoir and a charged battery to the pump as s...

Страница 55: ...d pump Figure 73 Press Continue to disconnect the old pump from the PDA and wait for the pump to rewind Separate the used reservoir from the pump Chapter Disassembling the Reservoir dispose of the old reservoir and then assemble a filled reservoir and a charged battery to the pump as shown in the animation Figure 70 Press Continue to go to the next page Note Be sure to use a fully charged battery ...

Страница 56: ...After the new pump has been activated the PDA will show a confirmation screen Figure 75 3 From the confirmation screen Figure 75 press the Continue button 4 Holding the pump in the orientation shown in Figure 77 press the Prime Reservoir button Figure 76 The plunger will begin to move slowly Continue to press the button until you see a drop of insulin on the needle tip Figure 77 Now press Continue...

Страница 57: ... and press Continue Figure 79 6 Now choose whether or not to prime the cannula Figure 80 Upon completion the pump will begin to deliver Figure 78 Figure 79 Note Skip only if the infusion set was not replaced and thus the cannula doesn t need to be filled Figure 80 ...

Страница 58: ...ou should replace the reservoir 1 From the Home Screen choose the Actions button andthentheNewReservoirbuttontoentertheNew Reservoir Wizard Remove the pump and reservoir from the infusion set as shown in Figure 81 Press Continue Figure 82 the pump will rewind and the PDA will display the next page of the wizard Before proceeding to the next step you should remove and replace the infusion set Chapt...

Страница 59: ... then assemble a filled reservoir and a charged battery to the pump as shown in the animation Figure 83 Press Continue Figure 84 to go to the next page Note Be sure to use a fully charged battery A low battery may require you to change reservoirs more frequently resulting in wasted insulin Figure 83 Figure 84 ...

Страница 60: ...nue to press the button until you see a drop of insulin on the needle tip Figure 85 The background of the Next button will be enabled when it changes from grey to green Press Continue to go to the next step 4 Connect the pump to the infusion set as shown in Figure 87 and press Continue Figure 88 Figure 86 Figure 85 Needle Tip Figure 87 Figure 88 ...

Страница 61: ...ow choose whether or not to prime the cannula Figure 89 Upon completion the pump will begin to deliver Note Skip only if the infusion set was not replaced and thus cannula doesn t need to be filled Figure 89 ...

Страница 62: ... Prior to testing use either alcohol or soapy water to disinfect the sampling site Use warm water to increase blood flow if necessary Dry your hands and the sampling site ensuring that there is no soap residue remaining Lancet Lancet Holder Release Button Cocking Barrel Safety Cap Application It is used to determine blood glucose concentrations in whole fresh capillary blood It can be used for bot...

Страница 63: ...to the lancing device avoid touching the lancet needle tip Figure 92 4 Adjust the puncture depth by rotating the depth adjustor the lancing device has 10 puncture depth settings To reduce discomfort choose the lowest setting that still produces an adequate blood sample Figure 93 Depth Adjustment 1 4 for delicate skin 5 7 for normal skin 8 10 for thick or calloused skin 4 5 Figure 90 Figure 91 4 5 ...

Страница 64: ...ger to promote better blood circulation Figure 95 7 Holding the lancing device against the side of the finger to be lanced press the release button and then put down the lancing device Massage forward slowly from the base of your finger to the tip to increase the sample size Figure 96 Note To reduce pain lance on the sides of the fingertips where there are less nerve endings Rotate finger location...

Страница 65: ...hare lancets with other people To avoid cross contamination always use a new sterilized lancet Do not reuse lancets Avoid contaminating lancets with hand lotion detergents oil and other debris Figure 97 Figure 98 Reminder Lancing devices and lancets should not be shared Each person should have his own lancing device and lancets Clean your lancing device before and after use with alcohol or a disin...

Страница 66: ...lood Glucose If the display is on insert a Wellion MICRO test strip and the blood glucose meter screen will appear Figure 100 After the strip has been inserted apply blood as shown on the screen When enough blood has been applied the screen will count down 5 seconds and then display the test result as in Figure 101 Figure 99 Figure 100 Figure 101 Test Result Area User Actions ...

Страница 67: ...lator If the Bolus Calculator is enabled in the Settings Menu the button turns green after a blood glucose reading has been recorded After the test has been completed slide the test strip ejector to pop out the test strip Ejecting the test strip or pressing the back button will return you to your last screen Note Your blood glucose level is automatically saved to history upon leaving the BG meter ...

Страница 68: ...e testing 3 Bring your PDA test strips and control solution to the lab 4 Ensure that the time between tests with your PDA and the laboratory is within 15 minutes 5 Wash and dry your hands before obtaining a blood sample 6 Make sure you closely follow the instructions in this manual Test results may show small deviations this may due to the following reasons Blood oxygen and red blood cell count va...

Страница 69: ...that the meter or test strips are not working properly if you suspect that your test results are inaccurate or inconsistent with the way you feel or if you suspect the meter is damaged 1 If the display is on insert a test strip and the blood glucose meter screen will appear Check mark the control solution checkmark box to indicate that you are doing a quality control test The PDA will display an a...

Страница 70: ...istory and the test result tags will be greyed out Figure 104 If the control solution results are outside of the reference range Confirm you are matching the correct range Control Solution 1 results should be matched to the CTRL1 range printed on the test strip vial Check the expiration date of the test strip and control solution Make sure that the packages have not been opened for more than 6 mon...

Страница 71: ...r your blood glucose reading manually This is especially useful if you use a separate blood glucose meter The entry will be stored in your history and can be used with the bolus calculator From the Home Screen choose the Actions button and then the Enter BG Reading Manually button to enter the manual entry screen Figure 105 Using the and buttons enter your blood glucose reading select the appropri...

Страница 72: ...er Name and press OK Pressing the OK Button will return you to the main BG Reminders screen and your new BG reminder will appear Now you can enable disable the reminder by checking unchecking the box Figure 108 Figure 106 Figure 108 Figure 107 Note If you would like for this reminder to repeat every day click the check mark box labeled Repeat this Reminder Note If a BG Reminder is activated the ic...

Страница 73: ...with a new strip Make sure there is enough blood to fill the test window Temperature exceeds operation range Move to a place within the normal operating temperature range and repeat the test Test result is below the measurement range Repeat test If you see the same result contact your healthcare professional immediately Test result is above the measurement range Repeat test If you see the same res...

Страница 74: ...ing The bolus calculator can also take into account the amount of insulin that is currently being used in your body and make corrections to the suggested bolus size Note The Bolus Calculator requires the following information 1 Current blood glucose level from internal BG meter 2 Target blood glucose level user setting ask your doctor 3 Carbohydrate ratio ask your doctor 4 Carbohydrate intake user...

Страница 75: ...olus U Current BG Level Target BG Level mg dL or mmol L Insulin Sensitivity Factor mg dL U or mmol L U Note If Negative Correction is ON a correction bolus is always calculated If Negative Correction is OFF the correction bolus will only be calculated if your current BG level is HIGHER than the target BG level Note The Bolus Calculator is disabled by default Please enable this feature in the Setti...

Страница 76: ...ose that you are not going to eat something the bolus calculator will not take into account carbohydrates that you will eat Note You can estimate the amount of carbohydrates contained in your food by reading the food packaging consulting carb counting books or by referring to the PDA s food library The amount of food and preparation method can have a large effect on the total amount of carbs b If ...

Страница 77: ...ed to calculate the suggested bolus including BG Reading carb intake and active insulin The last item of this suggestion is the bolus suggestion c Action Buttons Extend Bolus Press to choose extended bolus features see Chapter Extended Boluses Start Press to begin the bolus A confirmation window will open press OK to confirm or Cancel to abort Details Press to open a window that describes how the ...

Страница 78: ...s used to calculate the meal boluses Since everyone has a different metabolism set this value under the guidance of a physician Settings FromtheHomeScreen youcannavigatetotheBolusCalculatorsettingsbypressing Settings then Insulin Delivery Settings 1 Target Blood Glucose Range Set the default Target Blood Glucose Range first If desired you can set different Target Ranges for different time periods ...

Страница 79: ... s values are different choose your settings under the guidance of your physician 4 Negative Correction Click to enable or disable the Negative Correction feature 5 Active Insulin Time Set the default Active Insulin Time desired ...

Страница 80: ...can choose any calendar day or press the or button to scroll to the previous or next day Graph Display If you hold the PDA in landscape orientation the PDA will show the day s information in Graph Display mode Figure 113 Figure 112 Figure 113 Below the date you can see the day s BG average Total Carbs Total Insulin and of total insulin that was for boluses The grey area shows time stamped event en...

Страница 81: ...choose different filters to show for example the averages of all readings that were taken Before After Exercise or Before After a meal The Graphs show two types of information 1 Blood Sugar Carbohydrates For each blood glucose test reading a dot is shown on the upper graph Each record of carbohydrate intake is shown with a green vertical line 2 Insulin Delivery Amount Basal rates are shown as the ...

Страница 82: ... in a calendar format This information includes BG readings carbohydrates and boluses The left side of the screen shows the time while the top of the screen shows the day You can scroll through different hours and tap different time periods to view detailed information regarding BG level Carbs eaten and bolus sizes At the very top of the screen you can change week by pressing the and buttons Figur...

Страница 83: ...rmat or leave the box empty for 12 hour format About the System From General Settings choose About System 1 Software version Shows the software version of PDA and Pump 2 PDA Serial Number Shows the serial number of the PDA 3 Pump Serial Number Shows the serial number of the pump that is currently being controlled by the PDA This number is also printed on the pump housing Figure 116 Warning Executi...

Страница 84: ... the General Settings screen press the Display option 1 Brightness Choose the Brightness option to adjust the display brightness You can manually adjust the screen brightness or choose Automatic Brightness to have the PDA adjust automatically 2 Screen Timeout Choose the Screen Timeout option to adjust the amount of time that the display will turn off due to inactivity User Settings Press User Sett...

Страница 85: ...l important settings before restoring factory settings Note The Bluetooth function requires a microSD card to be installed Bluetooth From the General Settings screen choose Bluetooth Figure 117 1 Bluetooth On Off Check the checkbox to turn on Bluetooth The Bluetooth logo will appear in the status bar More options will appear if Bluetooth is on 2 Device Name Choose Machine Name to give your PDA a u...

Страница 86: ...evices in the list the PDA has following Bluetooth options a If a device in the list is not paired press the device name to pair with the PDA and a pop up window will open to enter the pairing code Enter the code and accept to pair a new device Figure 120 b If a device is already paired with the PDA pressing the device name will open a dialog box Figure 121 that will allow you to either export his...

Страница 87: ...s no user input button push for a set amount of time 15 minutes before shutdown the PDA will begin to beep to issue a warning that auto off will occur soon If there is still no button push the pump will stop delivery and both the pump and PDA will issue an alarm to tell the user that delivery has stopped Food Database The food database is an extra function that can provide carbohydrate content dat...

Страница 88: ...ber that rewinding the pump will require priming the reservoir again After Suspend mode has been activated the PDA returns to the Home Screen and the information area of the Home Screen will display the amount of time that insulin delivery has stopped The Pause button will become a Resume button as Figure 123 Ifyouwouldliketoresumeinsulindelivery presstheResumebutton Aconfirmation dialog box will ...

Страница 89: ...has stopped due to technical failure requiring the user to intervene in the operation of the pump change the pump or possibly inject insulin manually to control BG levels Low priority alarms occur to alert the user that something will occur in a short period of time but insulin delivery continues normally Users should be aware of this information and make plans in advance to ensure that treatment ...

Страница 90: ... Low Priority Steady Yellow Light None Yes Audio Alarm Volume Device Sound Pressure Level dB Pump None PDA 60 90 Pump Alarms Alarm Description Priority Level Alarm Signal Solution Action No Insulin Remaining Medium Vibration There is no more insulin and delivery has stopped The pump will automatically re wind Replace the reservoir and check your blood glucose level Blockage Detected Occlusion Medi...

Страница 91: ... enough insulin left in the reservoir to execute the requested bolus Prepare a new reservoir to be used after the old one is empty Pump Battery Level is Low Low LED Vibration The pump battery level is below 5 Please prepare a fully charged battery for replacement Note Unexpected delivery stoppage When this notice appears the pump infusion has been stopped and the pump will automatically rewind Ple...

Страница 92: ...check your blood glu cose level Unexpected insulin delivery stoppage Medium LED Vibration Insulin delivery has stopped Check your BG level Replace reservoir infusion set If prob lem persists contact the sup plier for guidance Pump Battery Exhausted Medium LED Vibration Delivery has stopped The pump will automatically re wind Please replace the de pleted battery with a fully charged battery Cannot ...

Страница 93: ...ibu tor for repair or replacement Note If a medium priority alarm occurs the pump will automatically rewind and stop all insulin delivery A pop up window will appear on the PDA display to show more information and proposed solutions to the alarm Press OK to close the pop up window You must now replace the reservoir to re initialize the system and continue delivery Note When the PDA gives an alarm ...

Страница 94: ...o send the alarm information wirelessly to the PDA 4s T5 T4 The amount of time between when the PDA receives the alarm to issuing the alarm signal 0 1s Figure 125 ALARM SIGNAL generation Algorithm variable response ALARMLIMIT Instantaneous signal from PATIENT Normalized variable PHYSIOLOGICAL ALARM CONDITION Graphical Representation of Alarm Delay The alarm system is distributed if a pump sensor d...

Страница 95: ...a soft damp cloth Use another cloth to dry 2 Disinfect with an alcohol wipe 3 Do not use solvents nail polish remover or paint thinner to scrub the outer surface 4 Keep the pump dry avoid water 5 Do not use any lubricant PDA 1 Clean the outer surface using a mild detergent and a soft damp cloth Use another cloth to dry 2 Disinfect with an alcohol wipe 3 Do not use solvents nail polish remover or p...

Страница 96: ...autoclave your pump or PDA Avoid Immersion in Water The pump is rated IPX4 splashproof Do not bathe swim or otherwise immerse your pump in water If you accidentally soak the pump with water it may not function correctly The PDA is not splashproof and thus should be kept away from water at all times Test Strips Use only Wellion MICRO blood glucose test strips with the PDA Store test strips in a cle...

Страница 97: ...ial was first opened and discard after 6 months Test Strip Precautions For in vitro diagnostic use Use the test strip immediately after removing it from the package otherwise the test results may not be accurate Do not use test strips that are torn bent or damaged in any way Do not reuse test strips Keep the test strip packaging away from children and pets Consult your physician or healthcare prof...

Страница 98: ...nge 5 30 C 41 86 F Do not refrigerate or freeze the control solution Ifthecontrolsolutioniscold donotuseuntilithaswarmedtoroomtemperature Do not use expired control solution Control solution may be used for 6 months after the bottle is opened for the first time Please take note of the date that the bottle was first opened and discard after 6 months Do not use beyond the expiration date Control Sol...

Страница 99: ...is essential therefore that you test your blood glucose levels at least four times per day If your blood glucose is out of range check the pump and infusion set to ensure that the necessary amount of insulin is being delivered Wireless Connection The pump and PDA communicate wirelessly and when the PDA sends instructions to the pump they must be within an acceptable distance The pump and PDA have ...

Страница 100: ...nal is still weak move the PDA closer to the pump If the situation persists please contact customer service Disposal When you replace the pump portable controller and its attachments please do not throw them away Take them to an electronics recycling facility or return to our company Do not discard damaged or expired batteries Please dispose of batteries according to local recycling laws Transport...

Страница 101: ...101 Other Considerations When dealing with potentially contagious substances such as blood or reagents use protective gloves or other protective coverings if skin exposure is likely ...

Страница 102: ...nce IPX4 IPX0 Alarm Prompts LED Yellow Vibration Audio LED Yellow Screen History Storage Automatically Syncs to PDA Browse by Screen Display None 3 2 inch color touchscreen Battery 70 mAh 1000mAh Low Reservoir Alarm Threshold 10 50U in increments of 5U 10U by default Auto Off Enable Disable Disabled by default Auto Off Time Range 1 24 hours 1 hour increments 10 hours by default Memory Behavior Dur...

Страница 103: ...rates remembered Default is Off Bolus Size 0 025U 35U 3 Presets Bolus Increment 0 025 0 05 0 1 0 5 1 U Default 0 1 U Max Bolus Size 1 35U programmed in 1U increments Default is 10U Extended Bolus Programmed in U or of total bolus Default is Off Extend time 0 5 8 hours in increments of 0 5 hr Quick Bolus On Off default is off Quick Bolus Increment 0 1 2U Default is 0 1 U Blood Glucose Meter Attribu...

Страница 104: ...Time 2 6 hrs in 0 5hr increments no default value Bolus Delivery Bolus Steps Volume per Step Time Interval Between Steps Infusion Speed per Minute 0 05 U 0 5 μl 1s 3 U Infusion Precision At 1U h delivery rate the error was measured at 0 4 as shown in Figure 126 When the delivery rate was set to 0 01mL hr the measured flow is shown in Figure 127 Figure 126 Figure 127 Note The above test results wer...

Страница 105: ...t Rate 3U hr 50 sec 53 sec Medium Rate 1U hr 150 min 160 min Slow Rate 0 025U hr 100 hrs 105 hrs Overdose Underdose The pump contains sensors whose sole purpose is to verify the infusion accuracy If the actual amount of delivery is more or less than the requested amount this is called an overdose or underdose The sensors in the pump can detect overdose or underdose situations and compensate automa...

Страница 106: ...esotherthanthosespecifiedforthedeviceisnotrecommended They may result in increased emissions or decreased immunity of the device The device should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the device should be observed to verify normal operation in the configuration in which it will be used The basic performance is described in the table below ...

Страница 107: ...ronment guidance RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power su...

Страница 108: ...rential mode 2 kV Common mode 1 kV Differential mode 2 kV Common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 s 5 Ut 95 dip in Ut for 0 5...

Страница 109: ...nsmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 10 V m 80MHz 2 5GHz 3V m a Field strengths from fi...

Страница 110: ...Separation distance according to frequency of transmitter m 150kHz 80MHz d 1 2 P 80MHz 800MHz d 1 2 P 800MHz 2 5GHz d 2 3 P 0 01 0 1 1 10 100 0 12 0 38 1 2 3 8 12 0 12 0 38 1 2 3 8 12 0 23 0 73 2 3 7 3 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmit...

Страница 111: ...F Applied Part Manufacturer Water Resistance Level Lot Number Recyclable Serial Number Do Not Dispose with Household Waste Sterilized by EO Keep Dry Biohazard Control Solution Range In Vitro Diagnostic Device Keep Away From Heat and Radiation Sources Non Ionizing Radiation Class 2 Equipment See Instructions for Use ...

Страница 112: ...rk 10 7221 Marz AUSTRIA www medtrust at www wellion at W19 32EN RevA 2021 03 MicroTech Medical Hangzhou Co Ltd No 9 Haishu Road Yuhang District Hangzhou Zhejiang China LOTUS NL B V Koningin Julianaplein 10 1eVerd 2595AA The Hague Netherlands INSULIN PUMP SYSTEM ...

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